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NCT07713732
TLN-499 in Combination With Venetoclax in Patients With Relapsed/Refractory Solid Tumors
Conditions: Small Cell Lung Cancer ( SCLC ), Neuroendocrine Cancer, Malignant Pleural Mesotheliomas (Mpm), Synovial Sarcomas
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 120
Sponsor: Treeline Biosciences, Inc.
Location: COBL Clinical Trials - Christ O'Brien Lifehouse Camperdown New South Wales
Summary
The purpose of this first-in-human study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of TLN-499 in combination with venetoclax in participants with relapsed/refractory solid tumors.
Eligibility Criteria
Inclusion Criteria:
1. Adults ≥18 years of age
2. Histologically confirmed relapsed/refractory SCLC, neuroendocrine cancer, malignant pleural mesothelioma, or synovial sarcoma
3. Measurable disease per RECIST v1.1 or mRECIST
4. ECOG performance status 0-1
5. Adequate hematologic, hepatic, renal, and coagulation function.
6. Life expectancy ≥12 weeks
7. Signed informed consent
Exclusion Criteria:
1. Active brain metastases
2. Major surgery or severe trauma within 4 weeks before first dose
3. Significant uncontrolled medical conditions preventing study participation
4. Use of prohibited concomitant medications
5. Previous conditions that would interfere with study assessments or safety
Source: ClinicalTrials.gov (NCT07713732). StuddyBuddy aggregates publicly available trial information.